Kornimate/medical-research-clean huggingface dataset:
radiostereometric analysis of acetabular wear and periprosthetic bone mineral density changes in hemiarthroplasties

Conditions: Femoral Neck Fractures; Bone Density; Acetabular Wear; Hemiarthroplasty

Summary: substudy and continuation of hemi-sab-uus (nct00491673) study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and measurements of periprosthetic bone mineral density in cemented and uncemented hemiarthroplasties in patients with femoral neck fractures. null hypothesis: no difference in acetabular wear or in bone mineral density changes between cemented and uncemented hemiarthroplasties

patients are randomised to treatment with cemented or uncemented bipolar hemiarthroplasty. 1mm tantalum markers are inserted in the pelvis during surgery. rsa x-rays and dexa measurements conducted postoperatively, after 3 and 12 months. follow-up visits and clinical examination at 3 and 12 months.

Eligibility criteria:
inclusion criteria: * femoral neck fracture * 65 years or older * able to walk independently exclusion criteria: * cognitive dysfunction * infection * fracture caused by malignant disease

Keywords: fracture arthroplasty wear osteoporosis bone
evaluation of the effect of hydration about orthostatic hypotension in the elderly. difference with venous compression

Conditions: Orthostatic Hypotension

Summary: primary objective: to compare the decrease in systolic blood pressure between hydration and venous contention when switching to a standing position. hypothesis in that hydration is better than venous contention. secondary objective: to evaluate the effect of hydration on lowering systolic blood pressure during the passage standing in elderly patients with orthostatic hypotension. inclusion criteria: patient aged over 75 years old with orthostatic hypotension proved to 1 and / or 3 min

day 0: confirmation of the orthostatic hypotension, without prevented measures two groups randomized : * group 1: first day (day 1), orthostatic hypotension test after hydration by three large glasses of clear liquid (33cl). second day (day 2), orthostatic hypotension test with venous contention in the morning. * group 2: first day (day 1), orthostatic hypotension test after implementation of venous contention in the morning. second day (day 2), orthostatic hypotension after hydration by three large glasses of clear liquid (33cl).

Eligibility criteria:
inclusion criteria: * patient aged 75 and older with orthostatic hypotension proved to 1 and / or 3 minutes. * written consent of the subject * hospitalization or stay expected minimum 3 days * affiliation to a social security scheme exclusion criteria: * bedridden patient or without possibility of verticalization * patient who can't stand up (pulmonary embolism with high risk) * patient who refuse to participate in the study * patient with legal protection * state or condition that may affect the stability of blood pressure during the study (hyperthermia, modification antihypertensive treatments less than 48 hours before inclusion...) * pathology preventing hydration: heart failure with less than 1 liter water restriction, swallowing disorders preventing hydration orally, inability to nutrition and hydration orally * intravenous or subcutaneous hydration (intravenous or subcutaneous treatments not included) * patient who can't have venous contention: blue phlebitis, septic thrombosis, arteritis with score less than 0.6, varicose ulcers during treatment

Keywords: orthostatic hypotension in the elderly efficacity of hydration difference between hydratation and venous contention
clinical verification of peptide biomarkers for type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: although diabetes has been controlled since insulin became available, it is still considered incurable and poses serious threats to human health. reports have suggested that the hyperglycemic condition of patients with diabetes mellitus may be greatly alleviated or even reversed if it could be controlled at an early stage of diabetes. thus, early detection and diagnosis of diabetes and prediabetes are become increasingly important in the treatment and prevention of diabetes. diabetes mellitus is currently diagnosed by recurrent or persistent hyperglycemia. in an effort to identify novel biomarkers for diabetes, research has shown that neither plasma glucose nor glycated hemoglobin (hba1c) levels are unable to be used in the early detection of diabetes. in this work, the investigators have found 8 biomarker candidates by developing a standard-free, label-free ms-based proteomics method based on standard protein (human serum albumin, the highest abundance protein in human plasma) model in vitro. then, the investigators wanted to verify these biomarker candidates by clinical plasma samples to see if there is significant quantitative difference between normal people and diabetes patients.

the procedure of clinical study was: 1. to get plasma samples from hospital; 2. digestion of plasma protein-mixture by trypsin; 3. run mass spectrometry and monitor the amount of target hsa-peptides.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus cases; * impaired glucose tolerance cases; * normal glucose tolerance cases exclusion criteria: * type 1 diabetes mellitus cases; * gestational diabetes mellitus cases; * hepatitis patients

Keywords: type 2 diabetes mellitus peptide biomarker early diagnosis label free
comparison of cosmesis, patient satisfaction and quality of life in patients undergoing laparoscopic surgery

Conditions: Gynecologic Disease; Cosmesis; Patient Satisfaction; Quality of Life

Summary: to compare robot assisted versus conventional laparoscopic surgery performed for bening gynecologic disorders regarding cosmesis, patient satisfaction and quality of life

30 patients undergoing robot assisted laparoscopic surgery for bening gynecologic disorders and 30 patients undergoing conventional laparoscopic surgery for bening gynecologic disorders will be included in the study. all surgeries will be performed in the same hospital by the same surgeon. 6 months after the surgery the patients will be called and will be informed about the trial. after confirming that the questionnaires can be sent to them by e-mail, 4 questionnaires will be sent to the patients via e-mail. to evaluate cosmesis, patient satisfaction and quality of life vas (visual analogue scale), sf-12 (short form-12) health survey, biq (body image questionnaire) and posas (the patient and observer scar assessment scale) will be sent to the patients 6 months after the surgery. patients who have not completed the questionnaires will be called for reminders after 1 week. patients will be expected to complete the questionnaire completely and accurately.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of being gynecologic disorders * patients undergoing conventional laparoscopic surgery * patients undergoing robot assisted laparoscopic surgery * patients undergoing surgery in our hospital by the same surgeon * patients willing to participate in the study exclusion criteria: * malignancy * requirement of emergency procedure * pregnancy * visible previous abdominal scars or keloid * inability of patient to tolerate trendelenburg position or pneumoperitoneum * patients undergoing surgery by another surgeon or in an another hospital * mental impairment that would preclude giving informed consent

Keywords: cosmesis laparoscopic surgery patient satisfaction scar assessment quality of life
focus: the future of fecal calprotectin utility study for the diagnosis and management of inflammatory bowel disease (ibd)

Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Summary: hypothesis: fecal calprotectin will be useful in guiding the diagnosis and management of patients with inflammatory bowel disease. fecal calprotectin can be utilized as an alternative to colonoscopy in the management of patients with inflammatory bowel disease. objectives: by means of a survey from the ordering physician we would assess: primary endpoint 1. the percentage of time that the fecal calprotectin result caused the physician to change the management of a patient. secondary endpoints 1. to determine if the fecal calprotectin result influenced the number of endoscopies performed 2. to correlate how well the fecal calprotectin correlates with endoscopic findings when endoscopy was performed. 3. to assess the correlation between the fecal calprotectin level and symptoms as measured by the harvey bradshaw index or the partial mayo score (or full mayo score depending if endoscopy was performed).

patients will be identified as eligible by the attending gastroenterologist during the course of a usual consultation. patients will be referred to the research nurse in the doctor's office for further information regarding the study and informed consent will be obtained by the research nurse. upon enrollment, the physician or the research nurse will complete an online requisition form with a unique code which will provide the baseline data. the patient will be provided with the easy sampler™ collection kit and instructions on the use of this kit and location on where to send the specimen. the nurse will then send an email to the research nurse in the originating physician's office with the result of the calprotectin assay. the research nurse will review the result with the physician. after physician review, either the physician or the research nurse will then complete a follow up survey online. after completion of the assays and surveys, the data will be tabulated electronically from the online website and analyzed by the pi and/or co-investigators.

Eligibility criteria:
inclusion criteria: * subjects must be at least 19 years of age or older, they must be able to read and provide written consent in english. subjects will have gastrointestinal symptoms or be known to have inflammatory bowel disease whereby the clinician feels that obtaining fecal calprotectin may be useful in the care of the patient. patients must be able to collect a feces sample and return it for analysis within 3 days exclusion criteria: * known ischemic colitis, infectious enteritis or colitis, known colorectal cancer, history of extensive bowel resection, ostomy, current daily use of nsaids (aspirin, ibuprofen, naproxen, etc) or the inability to collect sample and return it within 3 days

Keywords: fecal calprotectin
a prospective, multicenter atherectomy study showing luminal gain in subjects with peripheral vascular blockages

Conditions: Peripheral Arterial Disease

Summary: to evaluate the safety and effectiveness of the dabra laser system in the atherectomy of peripheral vascular stenoses.


Eligibility criteria:
participants must meet all of the inclusion criteria to participate in this study: inclusion criteria 1. ability and willingness to give written informed consent and comply with follow-up requirements 2. pad with rutherford class 2-5 3. stenotic lesion(s) in the peripheral vasculature 4. subject is a candidate for atherectomy for infrainguinal peripheral artery disease angiographic inclusion criteria 1. target vessel with documented stenosis by angiography ≥70% and ≤100% by angiography (as determined by investigator) 2. target vessel ≤ 3.0 mm in diameter 3. target lesion ≤ 25cm in length 4. the lesion to be treated is not severely calcified 5. untreated ipsilateral iliac stenosis ≤70% (or tortuosity that might prevent advancing sheath to lesion) as applicable depending on access 6. no use of another atherectomy device in the same procedure 7. treatment site is not located in a graft 8. treatment site is not in, or distal to, a previously placed stent 9. no flow limiting dissection proximal, distal, or in the target lesion (prior to the use of the investigational device) participants meeting any of the exclusion criteria at the time of enrollment (index procedure/ intervention) will be excluded from study participation: exclusion criteria 1. age below 22 years 2. pregnant, breastfeeding, planning to become pregnant. if women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. subject must agree to use effective birth control measures for duration of study. pregnancy during study must be reported immediately. 3. myocardial infarction (mi) ≤ 60 days prior to procedure 4. cerebrovascular accident (cva) ≤ 60 days prior to procedure 5. endovascular or surgical procedure ≤ 30 days prior to procedure or a planned endovascular or surgical procedure within 30 days after the index procedure 6. disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast 7. subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated 8. life expectancy ≤ 12 months 9. patient is participating in another investigational drug or device study

Keywords: lower extremity peripheral arterial disease (pad)
growth hormone, igf-1 and medical treatment in acromegaly: are there effects on gut hormone physiology and postprandial substrate metabolism?

Conditions: Acromegaly

Summary: acromegaly is a rare hormonal disorder leading to increased morbidity and mortality. in the vast majority of cases, a pituitary somatotroph cell adenoma causes excess growth hormone (gh) secretion, leading to hepatic insulin-like-growth factor 1 (igf-1) hypersecretion. both the disease as well as its treatment with long-acting somatostatin analogs (la-smsa) and/or pegvisomant affect glucose and lipid metabolism, possibly contributing to increased cardiovascular risk. in this pilot study, the investigators want to explore insulin sensitivity, postprandial gut hormone response, lipid handling and adipocytokine profile in the following 4 groups: * controlled acromegalic patients on la-smsa (group 1) * controlled acromegalic patients on combination treatment of la-smsa and pegvisomant (group 2) * acromegalic patients without need for medical therapy after surgery (group 3) * healthy control subjects (group 4) furthermore, a longitudinal exploration will be performed in uncontrolled acromegalic patients (i.e. patients with serum igf-1 levels above age-specific thresholds and/or symptoms due to active acromegaly (excessive sweating , arthralgia)) on la-smsa monotherapy (group 5). in this group, insulin sensitivity, postprandial gut hormone response, lipid handling and adipocytokine profile will be explored before introducing pegvisomant and three months after normalisation of igf-1 levels. the investigators hypothesize that lipid and glucose handling will be less efficient in the controlled acromegalic patients on la-smsa than in controlled patients on combination therapy or after surgery, and that there will be no difference in substrate metabolism between healthy controls and controlled acromegalic patients on combination treatment or after surgery. further, they hypothesize that introducing pegvisomant in uncontrolled acromegalic patients will improve their postprandial lipid and glucose handling.


Eligibility criteria:
inclusion criteria: * diagnosis of acromegaly over 1 year ago, no changes in treatment schedule since at least 6 months (groups 1-3 and 5) or healthy volunteer without diagnosis of acromegaly (group 4) * patient is willing to participate and has signed the informed consent * age \> 18 years and \< 80 years * body mass index 18-40 kg/m² exclusion criteria: * biochemistry: liver function tests \> 3x uln; hba1c \> 58 mmol/mol * all untreated endocrine disorders including uncontrolled diabetes mellitus type 2 (i.e. hba1c \> 58 mmol/mol) * bariatric surgery; malabsorptive syndromes; hepatic or renal failure * current medication use: insulin, metformin, sulfonylurea, fibrates, incretin mimetics, dopamine agonists (for all but insulin, participation is allowed after a 2- week wash-out period) * abuse of alcohol or drugs * weight changes \> 10% of body weight during preceding 12 months

Keywords: acromegaly acromegaly treatment long-acting somatostatin analogs pegvisomant insulin sensitivity gut hormones lipid metabolism adipokines
reducing vertical transmission of hepatitis b in africa

Conditions: Hepatitis B Infection

Summary: hepatitis b virus is an infection that can be easily transmitted from women to newborns at the time of delivery. our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis b in africa. the revert-b study (reducing vertical transmission of hepatitis b in africa) is a clinical trial designed to test a new strategy of using antiviral medication in high-risk pregnant women and newborns to reduce the risk of hepatitis b transmission. the study will measure efficacy, safety, tolerability and adherence to medication.

the revert-b trial is a multi-center, phase iii, randomized 2x2 factorial study designed to test the efficacy of early maternal tdf vs standard duration and neonatal 3tc prophylaxis compared to matching placebo in preventing hbv mtct. eligible pregnant women with hbv in prenatal care (n=450) will be randomized 1:1:1:1 to one of four maternal and neonatal prophylaxis combinations (shown as a-d in the figure below). women will initiate daily oral tdf early (2nd trimester) or at the standard time per who guidelines (3rd trimester) and will continue tdf until delivery. the current who standard of care in pregnant women with hbv (eag+) in cameroon is tdf prophylaxis from 28 weeks until delivery. newborns will receive liquid 3tc or matching placebo for the first six months of life to provide coverage until the vaccine series is complete. all infants in the study will be offered the 4-dose hbv vaccine series starting at birth. the 2x2 factorial design allows for two simultaneous studies where we first assess efficacy of early maternal prophylaxis (aim 1) and secondarily assess efficacy of neonatal prophylaxis (aim 2). the study endpoint for both aims is the mtct rate (proportion of infants hbsag+) at 6-9 months of age. women and infants will be followed until 6-9 months after delivery and subaims will assess safety and adherence to maternal tdf and neonatal 3tc. plasma testing will be used to measure medication adherence.

Eligibility criteria:
inclusion criteria: * prenatal clinic patient, * age ≥16 years, * 14-32 weeks gestational age according to clinic dating based on lmp or ultrasound, * active hepatitis b with risk of vertical transmission (hbsag+ and hbeag+ or hbv dna \>1000 iu/ml), * plan to receive follow up care and deliver at study facility, * capable of providing informed consent. exclusion criteria: * hiv positive (according to hiv antibody testing performed at the initial prenatal visit) * known liver cirrhosis or end-stage liver disease, * elevated liver enzymes (alt \>5x upper limit of normal), * elevated serum creatinine (\>1.4 mg/dl) * currently taking tenofovir medication * allergy or intolerance to tenofovir study medication, * known fetal anomaly in the current pregnancy, * clinical illness requiring hospitalization at the time of enrollment * evidence of early labor at the time of enrollment.

Keywords: perinatal infection, hepatitis b in pregnancy
immediate effects of ankle mwm and taping on gait and balance in stroke patients

Conditions: Stroke

Summary: disorders caused by stroke may lead to significant limitations, especially in ankle range of motion, and may cause impairments in walking and balance functions. this limitation in ankle range of motion leads to difficulties in weight transfer, stability, and balance. as a result, there is a decrease in walking performance and an increased risk of falls. various interventions have been used to improve ankle dorsiflexion passive range of motion, including gastrosoleus muscle stretching, muscle strengthening training, functional electrical stimulation training, proprioceptive control training, taping, manual therapy, different mobilization techniques, and ankle mobilization with motion (mwm).there are limited studies investigating the immediate effects of mwm and taping on gait and balance in stroke patients. this study was planned to investigate the effect of mulligan's ankle mwm technique and talus stabilization taping on spatiotemporal gait and balance parameters in stroke patients.


Eligibility criteria:
inclusion criteria: 1. having a unilateral stroke for more than three months, 2. being able to walk 10 meters without an assistive device, 3. being able to walk unassisted before having a stroke, 4. having a score of 3 or lower on the modified ashworth scale (mas), 5. be able to follow simple verbal instructions, 6. being volunteer exclusion criteria: 1. having had more than one stroke, 2. cerebellar involvement, 3. having severe visual impairment, 4. having cognitive impairment, 5. severe aphasia, 6. apraxia, 7. having contraindications for joint mobilization (e.g. ankle hypermobility, trauma, inflammation), 8. have significant lower limb problems such as fractures or arthritis, 9. having undergone musculoskeletal surgery less than 6 months ago, 10. having joint contracture in the paretic ankle that prevents walking.

Keywords: stroke gait mobilisation mulligan balance
paradise: predicting af after cardiac surgery

Conditions: Atrial Fibrillation New Onset

Summary: the paradise study aims to develop and validate prediction tools to identify patients at risk of atrial fibrillation (af) after cardiac surgery.

atrial fibrillation (af) is a common abnormal heart rhythm. af causes the heart to beat irregularly and sometimes very rapidly. about 30-50% of patients develop af after heart surgery. these patients stay longer on the intensive care unit (icu) after surgery, are more likely to develop complications and have a higher risk of dying. avoiding af is important. some drugs, including beta blockers and amiodarone may help prevent af if given after surgery. however, these may also lead to complications (such as lung damage). it is therefore important to identify which patients are most likely to benefit from these treatments (i.e., where the benefits outweigh the risks). there are existing tools designed to predict the risk of suffering af after heart surgery. however, they are unreliable and therefore not used in clinical practice. a modern, reliable risk prediction tool is needed. the paradise study will develop and test new prediction tools to identify which patients are most at risk of developing af after heart surgery. the investigators will focus our tools on those patients who most commonly develop af, such as those who have had surgery to repair a valve or blood vessel in their heart. to do this the investigators will: * review the medical literature and assemble a panel of medical experts to create a list of known factors that affect patients' risk of af after heart surgery * use a large uk general practice database (caliber) to see whether the investigators can find new risk factors. * ask the expert panel to agree a list of known and new risks factors to be included in the prediction tool. * develop two new prediction tools using an existing american cardiac surgery database (the partners research database). the first will be used before surgery, the second immediately following surgery. two models are needed as events during surgery may alter the risk of af. * test how reliably our new tools predict which patients suffer af after surgery, with data from large uk (united kingdom) nhs (national health service) heart centres, one us hospital (brigham) and a uk clinical trial (tight-k). * the investigators will work with two charities (af alliance and stopafib) to share our results with patients and the wider public.

Eligibility criteria:
inclusion criteria: * patients 18 years or over * admitted to hospital for any cardiac surgery exclusion criteria: * patients who have requested that their data not be used for research (e.g. nhs opt-out)

Keywords: new onset atrial fibrillation cardiac surgery